Next Topics

Low Back Pain

CTAF, ICER, Washington State

ICER will develop a report assessing the comparative clinical effectiveness and value of certain non-pharmacologic, non-invasive interventions for chronic low back and neck pain. The report will be the subject of a October 19, 2017 meeting of the California Technology Assessment Forum.

A preliminary list of interventions will be available in a draft scoping document scheduled to be posted on or about April 10, 2017.

Date of review: October 2017


Low back disorders are an exceedingly common complaint, with a lifetime prevalence ranging from 54-80%.  Chronic low back pain may be seen in 25-60% of patients one year or longer after an initial episode.  The economic impact of low back pain is substantial.  It is the fifth most common reason for all physician visits in the U.S., and is responsible for direct medical costs that approach $30 billion annually.  In addition, low back pain is a major cause of lost productivity; it is estimated that 2% of the U.S. work force is compensated for back pain or injury each year.

Intervention of interest: Lumbar fusion

Date of review: October 2015

Interventions of interest:

Automated percutaneous  lumbar discectomy
Coblation nucleoplasty
Epidural steroid injections
Intradiscal electrothermal therapy
Interdisciplinary rehabilitation programs that combine physical therapy, exercise, workplace interventions, and cognitive retraining
Interspinous spacer systems
Laminectomy
Radiofrequency denervation
Spinal fusion
Surgical lumbar discectomy

Date of review: June 2011


Arthritis

New England CEPAC

Rheumatoid arthritis (RA) is the most common autoimmune inflammatory arthritis in adults, affecting approximately 1.5 million Americans. RA is more common in women and may occur at any age, with peak incidence occurring at ages 50-60 years. RA is typically characterized by morning stiffness and symmetrical joint swelling of the feet, hands, and knees, although any joint (and in some cases, internal organs) may be involved. The course of RA may be complicated by cardiac, hematologic, and other extra-articular manifestations.

Interventions of Interest (subject to change):

TNF Inhibitors

  • Adalimumab (Humira®, Abbvie)
  • Certolizumab pegol (Cimzia®, UCB)
  • Etanercept (Enbrel®, Amgen)
  • Golimumab (Simponi®, Janssen)
  • Infliximab (Remicade®, Janssen)

CD20- directed cytolytic antibody

  • Rituximab (Rituxan®, Genentech)

Tcell inhibtor

  • Abatacept (Orencia®, BMS)

IL-6 inhibitors

  • Sarilumab (Sanofi)
  • Tocilizumab (Actemra®, Genentech)

JAK- inhibitors

  • Tofacitinib (Xeljanz®, Pfizer)
  • Baricitinib (Eli Lilly and Co.)

Date of Review: March 2017

 


Atopic Dermatitis

Midwest CEPAC

Atopic dermatitis (eczema) is a chronic/chronically-relapsing skin condition characterized by itching and dry skin. Atopic dermatitis is common. It affects 5-20% of children worldwide, and approximately 11% of children in the US. It is also estimated to affect around 3-7% of adults in the US. Management of atopic dermatitis can create burdens for the family, and the disorder can decrease quality of life. Itching, in particular, can disrupt sleep and lead to daytime sleepiness, irritability, and psychological stress, and cosmetically important lesions can lead to social stress and isolation.

ICER’s report will evaluate the comparative clinical effectiveness and value of two emerging therapies for atopic dermatitis: crisaborole and dupilumab. Crisaborole will be evaluated based on its expected indication in the treatment of mild-to-moderate atopic dermatitis in children and adults; separately, dupilumab will be evaluated for its expected indication in the treatment of moderate-to-severe atopic dermatitis in adults.

Interventions of Interest:

  • Crisaborole (Eucrisa™, Pfizer, Inc.)
  • Dupilumab (Dupixent®, Sanofi and Regeneron, Inc.)

Date of Review: May 2017


Orphan Drug Summit

ICER

ICER will host a multi-stakeholder policy summit to discuss methods for assessing the value of new drugs for rare conditions. The summit will include discussion of how these methods can be applied to recommend fair prices that reflect the value of orphan drugs to patients and the health system to allow for broader insurance coverage for innovative new treatments.

To facilitate the discussion, ICER will produce a Briefing Paper on Spinraza™ (nusinersen, Biogen), a new drug for spinal muscular atrophy (SMA) recently approved by the FDA. The paper will review the evidence on the clinical effectiveness of Spinraza and seek to understand the costs of the drug’s development as a case study. It will also compare methods used by academic researchers and others to evaluate the long-term value of drugs for rare conditions, including those affecting children. The Briefing Paper will not include an ICER value-based price benchmark, nor will the meeting involve a vote on the value of these drugs. Instead, the meeting will seek broad input from all perspectives on how the methods used by ICER and other groups can best be tailored to meet the challenge of assessing the value of orphan drugs and provide an objective foundation for discussions about fair pricing, insurance coverage, and payment mechanisms.


Osteoporosis

CTAF

Osteoporosis, the weakening of the bones through loss of bone mineral content and a decrease in bone quality, is a common disease of aging that affects approximately 10 million Americans. Approximately half of women and one quarter of men will suffer at least one fracture due to osteoporosis during their lifetimes. Experts estimate that there are approximately two million osteoporotic fractures each year, which results in $19 billion in related costs.3 By 2025, these figures are predicted to grow to approximately three million fractures and $25 billion in costs annually as the population of older Americans increases.

Interventions of Interest:

  • Abaloparatide (Radius Health, Inc.)
  • Romosozumab (Amgen, Inc. and UCB, Inc.)
  • Teriparatide (Forteo®, Eli Lilly and Co.)

Abuse-Deterrent Opioids

New England CEPAC

Opioids are used to treat cases of acute and chronic pain that arise from a variety of causes, ranging from trauma to palliative care for advanced illness. Every year, 100 million people in the United States suffer from pain, 9-12 million of whom have chronic or persistent pain. Although opioid therapy is an important component of pain management for many patients, the addictive and euphoric properties of these drugs make them liable to misuse, abuse, addiction, and diversion.

In an effort to help tackle the public health crisis of opioid dependence, misuse, and addiction that has emerged over the last decade, drug manufacturers have begun to develop abuse-deterrent formulations of opioid medications (ADFs). ICER will review available evidence on the comparative clinical effectiveness and comparative value of ADFs in order to inform decision-making by patients, clinicians and policy-makers, within the context of multiple efforts being undertaken to combat the opioid crisis. ICER’s review will also analyze the potential of ADFs to reduce the burden of prescription opioid abuse by evaluating their benefits and market penetration based on coverage policies and legislation.

Interventions of Interest:

  • Hydrocodone (Hysingla® ER, Purdue)
  • Hydrocodone (VantrelaTM, Teva)
  • Morphine (ArymoTM ER, Egalet)
  • Morphine + naltrexone (Embeda®, Pfizer)
  • Morphine extended release (MorphabondTM, Inspirion Delivery Technologies)
  • Oxycodone (OxyContin® TR, Purdue)
  • Oxycodone (XtampzaTM ER, Collegium Pharmaceutical Inc)
  • Oxycodone + naloxone extended release (TarginiqTM, Purdue)
  • Oxycodone + naltrexone (Troxyca® ER, Pfizer)

Date of Review: July 2017


Ovarian Cancer

Midwest CEPAC

ICER’s report will review evidence on the comparative clinical effectiveness and value of poly (ADP-ribose) polymerase (PARP) inhibitors for treatment of ovarian cancer.

Interventions of Interest:

  • Rucaparib (Rubraca™, Clovis Oncology)
  • Niraparib (Zejula™, Tesaro, Inc.)
  • Olaparib (Lynparza™, AstraZeneca)

Tardive Dyskinesia

New England CEPAC

past Topics

Feb 2017
CTAF

Multiple Sclerosis

Multiple sclerosis (MS) is a chronic, immune-mediated inflammatory demyelinating disease of the central nervous system (CNS). Approximately 400,000 Americans have MS, although this may be an underestimate, and the disease affects about twice as many women as men. Some patient groups, such as African Americans, experience a more rapid and severe clinical course. MS is the most common nontraumatic cause of permanent disability among young adults. The annual cost of MS in the United States is estimated to be $28 billion.

ICER’s review will incorporate treatments for two types of MS. The most common form of the disease is relapsing-remitting MS (RRMS), which affects 85% to 90% of patients with MS. RRMS is characterized by periodic relapses characterized by neurologic symptoms that diminish or resolve with treatment. The report will also review treatments for primary-progressive MS (PPMS), which affects approximately 10-15% of MS patients. PPMS is characterized by steadily worsening neurologic function without remissions or acute episodes.

Interventions of Interest:

Injectable Agents

  • Daclizumab (Zinbryta®, Biogen/AbbVie)
  • Glatiramer acetate (Copaxone®, Teva)
  • Glatiramer acetate (Glatopa®, Sandoz (Novartis))
  • Interferon beta-1a (Avonex®, Biogen)
  • Interferon beta-1b (Betaseron®, Bayer)
  • Interferon beta-1b (Extavia®, Novartis)
  • Interferon beta-1a (Rebif®, EMD Serono)
  • Peginterferon beta-1a (Plegridy®, Biogen)

Oral Agents

  • Dimethyl fumarate (Tecfidera®, Biogen)
  • Fingolimod (Gilenya®, Novartis)
  • Teriflunomide (Aubagio®, Sanofi-Genzyme)

Infused Agents

  • Alemtuzumab (Lemtrada®, Sanofi-Genzyme)
  • Natalizumab (Tysabri®, Biogen)
  • Ocrelizumab (Ocrevus®, Roche/Genentech)
  • Rituximab (Rituxan®, Roche/Genentech)

Date of Review: February 2017

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Nov 2016
New England CEPAC

Psoriasis

Plaque psoriasis is a common disease that causes red, scaly, raised lesions on the skin, most commonly on the elbows, knees, scalp, and back. Psoriasis affects about 2% of the population and significantly decreases health-related quality of life, particularly if lesions are in areas that can affect daily functioning (e.g., the hands or soles of the feet) or affect social functioning (e.g., the face). Psoriasis is a chronic inflammatory condition that is associated with systemic diseases including psoriatic arthritis, other autoimmune diseases, the metabolic syndrome, and cardiovascular disease.

Interventions of interest:

Anti-TNF agents:

  • Adalimumab (Humira®, AbbVie)
  • Etanercept (Enbrel®, Amgen, Inc.)
  • Infliximab (Remicade®, Janssen)

Anti IL-17A agents:

  • Secukinumab (Cosentyx®, Novartis)
  • Ixekizumab (Taltz®, Eli Lilly and Co.)
  • Brodalumab (Valeant Pharmaceuticals and AstraZeneca)

Anti IL-12/13 agent:

  • Ustekinumab (Stelara®, Janssen)

Anti-PDE4 agent:

  • Apremilast (Otezla®, Celgene)
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Oct 2016
Midwest CEPAC

Non-Small Cell Lung Cancer

Lung cancer is the number one cause of cancer death in the United States, expected to cause 158,000 deaths in 2016, and accounting for 26.5% of all cancer deaths. It is the second most common cancer in both men (after prostate cancer) and women (after breast cancer), with 118,000 and 106,000 new cases expected in 2016, respectively. Lung cancer includes different pathological types, broadly divided into small-cell lung cancer and non-small-cell lung cancer (NSCLC). NSCLC makes up about 85% of lung cancers and comprises mainly squamous cell carcinoma, adenocarcinoma, and large-cell lung cancer. Stage at diagnosis is a primary factor in patient survival, and patients with NSCLC commonly present with advanced disease.

Interventions of Interest:

Tyrosine kinase inhibitors:
  • Afatinib (Gilotrif®, Boehringer Ingelheim Pharmaceuticals, Inc.)
  • Erlotinib (Tarceva®, Genentech, Inc. and Astellas Pharma US, Inc.)
  • Gefitinib (Iressa®, AstraZeneca)
Immunotherapies targeting the programmed death 1 (PD-1) receptor or its ligand (PD-L1):
  • Atezolizumab (Tecentriq®, Genentech, Inc., Roche Group)
  • Nivolumab (Opdivo®, Bristol-Meyers Squibb Co.)
  • Pembrolizumab (Keytruda®, Merck & Co.)

Date of Review: October 2016

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Jul 2016
New England CEPAC

Obeticholic Acid

Obeticholic acid (OCA) is a novel bile acid analogue that has shown positive effects on biochemical markers of liver function in phase II trials (NCT00550862) and is currently under consideration by the FDA for treatment of primary biliary cholangitis (PBC) after failure of Ursodeoxycholic Acid (UDCA). Primary biliary cholangitis (PBC), which has until recently been called primary biliary cirrhosis, is a rare, chronic, progressive autoimmune liver disease that affects mainly middle-aged women. In the US, up to 130,000 individuals may have PBC.

In January 2015, obeticholic acid also received a breakthrough designation for treatment of non-alcoholic steatohepatitis (NASH) with concomitant liver fibrosis. Interim findings from the phase III trial are not expected to be available until March 2017; however, clinical interest in potential off-label use of obeticholic acid is likely to be great, given the lack of available treatments with liver-specific effects. NASH is form of nonalcoholic fatty liver disease (NAFLD) that can progress to cirrhosis, liver failure, and cancer. NASH is present in about 30 million adults in the US.

Intervention of Interest: Obeticholic Acid (Intercept Pharmaceuticals, Inc.)

Date of Review: July 2016

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Jun 2016
CTAF

Diabetes Prevention Programs

The Centers for Disease Control and Prevention (CDC) estimates that 29.1 million Americans have diabetes and 1.7 million adults are newly diagnosed with diabetes mellitus each year. The direct medical costs of diabetes were estimated to be $176 billion in 2012. Interventions to prevent diabetes have the potential to save the health care system substantial medical costs by reducing the incidence of diabetes and its associated complications. The Diabetes Prevention Program Trial (DPPT) demonstrated that the incidence of diabetes could be reduced using intensive diet and lifestyle counseling for individuals at very high risk for diabetes. Since publication of the trial results, many commercial programs have been developed to implement a scalable version of the DPPT intervention using fewer resources.

Intervention of interest: Diabetes prevention programs

Date of review: June 2016

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May 2016
Midwest CEPAC

Multiple Myeloma

Multiple myeloma (MM) is a blood cancer in which the bone marrow produces an overabundance of malignant plasma cells that emerge into the bloodstream. Ultimately, the proliferation of plasma cells can cause bone damage, anemia, low white blood cell counts, and kidney failure. Approximately 25,000 cases of MM are diagnosed in the U.S. annually, with three quarters of affected individuals over 70 years of age. There is no cure for multiple myeloma, but its progression can be relatively slow in many individuals, often involving multiple rounds of remission after treatment followed by a subsequent relapse. Recent advances in therapy have greatly improved the disease’s prognosis.

Interventions of interest:

Carfilzomib (Kyprolis®, Onyx) with lenalidomide (Revlimid®, Celgene) and dexamethasone
Daratumumab (Darzalex®, Janssen Biotech) monotherapy
Elotuzumab (Empliciti®, Bristol Myers-Squibb) with lenalidomide and dexamethasone
Ixazomib (Ninlaro®, Takeda) with lenalidomide and dexamethasone
Panobinostat (Farydak®, Novartis Pharmaceuticals Corp.) with bortezomib (Velcade®, Takeda Millennium) and dexamethasone
Pomalidomide (Pomalyst®, Celgene) with low-dose dexamethasone

Date of review: May 2016

 

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Mar 2016
New England CEPAC

Palliative Care

Palliative care is a management approach that provides symptom relief and comfort care to patients with serious or life-threatening illnesses, with the goal of improving quality of life for both patients and their families. Unlike hospice care, which is typically restricted to individuals with a prognosis of survival of six months or less, palliative care can begin at diagnosis and is often provided along with treatment aimed at prolonging life, such as chemotherapy or radiation for cancer. One of the primary objectives of palliative care is to help patients prioritize their goals of care, and may include conversations around advance care planning (e.g., a “living will”) depending the anticipated disease trajectory.

Intervention of interest: Palliative care in the outpatient setting

Date of review: March 2016

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Feb 2016
CTAF

Asthma

An estimated 22 million Americans have asthma, which causes the airways of the lungs to narrow or become blocked, making it hard to breathe. Among both young and old, asthma can have a significant impact on health and limit the ability to pursue many activities. Five to 10% of patients have severe asthma.

Intervention of interest: Mepolizumab (Nucala®, GlaxoSmithKline plc.)

Date of review: February 2016

 

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Feb 2016
CTAF

Diabetes Mellitus

The Centers for Disease Control and Prevention (CDC) estimates that 29.1 million Americans have diabetes and 1.7 million adults are newly diagnosed with diabetes mellitus (DM) each year. To treat diabetes, approximately 6 million Americans use insulin therapy as part of their treatment plan to control their blood glucose level.

Intervention of interest: Insulin degludec (Tresiba®, Novo Nordisk A/S).

Date of review: February 2016

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Feb 2016
Washington State

ECMO

Extracorporeal membrane oxygenation (ECMO) is a form of life support that provides cardiopulmonary assistance outside the body. ECMO may be used to support lung function for severe respiratory failure or heart function for severe cardiac failure. An ECMO circuit can be set up as veno-venous (VV) or veno-arterial (VA). VV-ECMO provides external gas exchange, bypassing the lungs and protecting them from high tidal volumes of ventilation that would otherwise be needed to oxygenate and ventilate the patient. VV-ECMO is indicated for patients with potentially reversible respiratory failure, including those with severe acute respiratory distress syndrome (ARDS), primary graft dysfunction following lung transplant, and trauma to the lungs.

Intervention of interest: Extracorporeal membrane oxygenation (ECMO)

Date of Review: February 2016

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